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Statements

Subject Item
n2:RIV%2F00216224%3A14740%2F12%3A00073090%21RIV14-MSM-14740___
rdf:type
skos:Concept n16:Vysledek
dcterms:description
Objectives Evaluate interim long-term tolerability, safety and efficacy of adjunctive perampanel, a novel alpha-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid (AMPA)-receptor antagonist, in patients with refractory partial-onset seizures. Materials and methods Study 207, an open-label extension (OLE) study (ClinicalTrials.gov identifier: NCT00368472), enrolled patients (1870 years) who completed one of two randomized, placebo-controlled, dose-escalation Phase II studies. The OLE Treatment Phase comprised a 12-week Titration Period (2 mg increments of perampanel every 2 weeks to 12 mg/day, maximum) and a Maintenance Period, during which patients continued treatment up to a planned maximum of 424 weeks ( 8 years). Interim analysis data cut-off date was 1 December, 2010. Results Of 180 patients completing the Phase II studies, 138 enrolled in study 207. At the time of interim analyses (approximately 4 years after study start), over a third (n = 53, 38.4%) remained on perampanel; 41. Objectives Evaluate interim long-term tolerability, safety and efficacy of adjunctive perampanel, a novel alpha-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid (AMPA)-receptor antagonist, in patients with refractory partial-onset seizures. Materials and methods Study 207, an open-label extension (OLE) study (ClinicalTrials.gov identifier: NCT00368472), enrolled patients (1870 years) who completed one of two randomized, placebo-controlled, dose-escalation Phase II studies. The OLE Treatment Phase comprised a 12-week Titration Period (2 mg increments of perampanel every 2 weeks to 12 mg/day, maximum) and a Maintenance Period, during which patients continued treatment up to a planned maximum of 424 weeks ( 8 years). Interim analysis data cut-off date was 1 December, 2010. Results Of 180 patients completing the Phase II studies, 138 enrolled in study 207. At the time of interim analyses (approximately 4 years after study start), over a third (n = 53, 38.4%) remained on perampanel; 41.
dcterms:title
Perampanel Study 207: long-term open-label evaluation in patients with epilepsy Perampanel Study 207: long-term open-label evaluation in patients with epilepsy
skos:prefLabel
Perampanel Study 207: long-term open-label evaluation in patients with epilepsy Perampanel Study 207: long-term open-label evaluation in patients with epilepsy
skos:notation
RIV/00216224:14740/12:00073090!RIV14-MSM-14740___
n16:predkladatel
n17:orjk%3A14740
n3:aktivita
n14:I n14:N
n3:aktivity
I, N
n3:cisloPeriodika
4
n3:dodaniDat
n8:2014
n3:domaciTvurceVysledku
n9:8132208 n9:9233075
n3:druhVysledku
n12:J
n3:duvernostUdaju
n11:S
n3:entitaPredkladatele
n19:predkladatel
n3:idSjednocenehoVysledku
158140
n3:idVysledku
RIV/00216224:14740/12:00073090
n3:jazykVysledku
n4:eng
n3:klicovaSlova
a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic
n3:klicoveSlovo
n5:antiepileptic%20drugs n5:post-synaptic n5:perampanel n5:epilepsy n5:glutamate n5:a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic%20acid n5:long-term%20safety n5:open-label%20extension
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[F9F5C50880D1]
n3:nazevZdroje
Acta Neurologica Scandinavica
n3:obor
n18:FH
n3:pocetDomacichTvurcuVysledku
2
n3:pocetTvurcuVysledku
10
n3:rokUplatneniVysledku
n8:2012
n3:svazekPeriodika
126
n3:tvurceVysledku
Gee, M. Squillacote, D. Vaiciene-Magistris, N. Rektor, Ivan Kumar, D. Krauss, G. L. Biton, V. Klapper, J. A. Kuba, Robert Bar, M.
n3:wos
000308205500008
s:issn
0001-6314
s:numberOfPages
7
n6:doi
10.1111/ane.12001
n13:organizacniJednotka
14740